247 CMR, § 21.04 - Non-resident Outsourcing Facility Registration Requirements

(1) In support of an application for a registration to operate a non-resident outsourcing facility, the applicant(s) shall submit:

(a) complete application forms;

(b) check or money order made payable in the proper amount to the "Commonwealth of Massachusetts Board of Registration in Pharmacy";

(c) proof of a valid, current registration with the FDA pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act;

(d) proof of an inspection by the FDA in connection with the section 503B of the Federal Food, Drug, and Cosmetic Act registration within the two years immediately preceding the application;

(e) if the applicant is an entity:

1. a certificate of good standing and legal existence issued by the Secretary of State, or the equivalent, in the state in which the entity was organized or formed, and other information concerning ownership and control, as the Board may require;

2. a statement of the name and address of each officer, director, or partner of the entity and the position held;

3. the "doing business as" (d/b/a) name of the entity; and

4. if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s);

(f) if the outsourcing facility is licensed or registered by the state in which it is located, proof of good standing from the licensing or registering authority in that state that was issued within three months; and

(g) any additional information, as required by the Board.

(2) All fees submitted to the Board in connection with an application for a non-resident outsourcing facility registration are nonrefundable.

(3) A non-resident outsourcing facility registration shall be non-transferrable.

Notes

247 CMR, § 21.04

Adopted by Mass Register Issue 1305, eff. 1/29/2016.